06 September 2016

Draft Reflection Paper on Extrapolation of Indications in Authorization of Biosimilar Products

The IPRF Biosimilars Working Group (IPRF BWG) has proposed the development of this Reflection Paper (hereby the Paper). The IPRF BWG suggests that the National Regulatory Agencies (NRAs) that participate in the IPRF consider the proposed principles in the Reflection Paper on the extrapolation of indication(s) in the authorization of biosimilar products (also known as follow-on biologics, subsequent entry biologics or similar biological medicinal products, etc.).

The Paper addresses the issues associated with the extrapolation of indications, proposes principles for the extrapolation and considerations of the proposed principles in the approval of biosimilar products. The Paper also includes the proposed scope of regulatory submissions for a biosimilar product applicant to receive the approval of an extrapolated indication(s). However, this Paper does not deal with the definition of the terminology associated with biosimilar products, the regulatory requirements in demonstrating biosimilarity, or other issues on the authorization of biosimilar products, which are subject to the policies and procedures on the biosimilar product regulations by each NRA.

The IPRF BWG is providing the draft documents to gain initial feedback. The documents at this stage comprise the draft Reflection Paper itself and four attachments.

Interested stakeholders are invited to provide feedback during a 2-months period.

Please note that the deadline for comments is 5 November 2016.

Comments should be provided using the template for feedback.

Name Filesize  
File Name: Attachment1_Gap_Analyses_of_Biosimilar_Guidelines_for_the_Extrapolation_of_Indications.pdf
File Size: 140KB
140KB
File Name: Attachment2_Biosimilar_Products_Approved_with_Extrapolated_Indications.pdf
File Size: 133KB
133KB
File Name: Attachmnet3A_Selected_Summary_of_Regulatory_Biosimilar_Reviews_by_Year.pdf
File Size: 301KB
301KB
File Name: Attachment3B_Selected_Summary_of_Regulatory_Biosimilar_Reviews_by_Agent.pdf
File Size: 233KB
233KB
The Paper addresses the issues associated with the extrapolation of indications, proposes principles for the extrapolation and considerations of the proposed principles in the approval of biosimilar products.
File Name: 160725_IPRF_BWG_Reflection_paper_final_draftver_1.3_IPRF_MC_Circulation.pdf
File Size: 547KB
547KB